Status:
UNKNOWN
SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss
Lead Sponsor:
Sound Pharmaceuticals, Incorporated
Collaborating Sponsors:
VA Puget Sound Health Care System
Conditions:
Lung Cancer
Head and Neck Cancer
Eligibility:
All Genders
19-80 years
Phase:
PHASE2
Brief Summary
Chemotherapy treatment with platinum based agents is well noted to cause ototoxicity. It is the objective of this study to determine the safety and efficacy of SPI-1005 at three dose levels when deliv...
Detailed Description
Chemotherapy treatment with the platinum containing chemotherapies (e.g. cisplatin, carboplatin) are well noted and studied for their ability to cause ototoxicity which includes hearing loss, tinnitus...
Eligibility Criteria
Inclusion
- Adult male and female subjects, 19-80 years of age;
- Confirmed diagnosis of advanced head and neck cancer or advanced lung cancer
- Voluntarily consent to participate in the study
- Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to screening and throughout the study or be using one of the following acceptable birth control methods:
- IUD in place for at least 3 months prior to study;
- Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion;
- Stable hormonal contraceptive for at least 3 months prior to study through completion of study;
- Surgical sterilization (vasectomy) of partner at least 6 months prior to study.
- Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study).
Exclusion
- Subjects previously treated with chemotherapy, antibiotics, or diuretics known to cause hearing loss in the last 90 days
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, otologic, or psychiatric disease
- Presence of alcoholism or drug abuse
- Participation in another investigational drug or device clinical trial within 30 days prior to the study
- Female subjects who are pregnant or lactating
Key Trial Info
Start Date :
January 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 23 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01451853
Start Date
January 15 2018
End Date
September 23 2019
Last Update
September 25 2017
Active Locations (1)
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1
VA Puget Sound Health Care
Seattle, Washington, United States, 98108